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NCT01896947
3T MRI Versus MR Arthrogram in SLAP Lesions
trial testing MRI in Superior Labrum Anterior Posterior Lesion. Withdrawn.
29 September 2024
Quick facts
| Lead sponsor | Henry Ford Health System |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 29 September 2024 |
| Primary completion | 29 September 2024 |
| Estimated completion | 29 September 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MRI — full drug profile →
Conditions studied
- Superior Labrum Anterior Posterior Lesion — all drugs for Superior Labrum Anterior Posterior Lesion →
Sponsor
Henry Ford Health System — full company profile →
Who can join
18 and older, any sex, with Superior Labrum Anterior Posterior Lesion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the diagnostic performance of three Tesla magnetic resonance imaging (3T MRI) compared to magnetic resonance arthrogram (MR arthrogram) in diagnosing superior labrum anterior posterior (SLAP) lesions. We hypothesize that 3T MRI will have non-inferior sensitivity compared to MR arthrogram in diagnosing SLAP lesions utilizing arthroscopy as our gold standard test. To evaluate our hypothesis, the investigators will include patients suspected to have a SLAP lesion on history and physical examination by a fellowship trained orthopaedic surgery. Patients will be offered advanced imaging (both 3T MRI and MR arthrogram) as well as arthroscopy for definitive diagnosis and treatment after consent is obtained. A fellowship trained musculoskeletal radiologist will perform and interpret the magnetic resonance tests while the arthroscopy will be performed by orthopaedic surgeons. The diagnostic characteristics of each imaging modality, including sensitivity, specificity, negative predictive value, and positive predictive value, will be compared to each other.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01896947 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Henry Ford Health System
- Last refreshed: 1 October 2024
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